PIVOT
A Randomised Controlled Trial of a Strategy of Switching to Boosted PI Monotherapy Versus Continuing Combination ART for the Long-term Management of HIV-1 Infected Patients Who Have Achieved Sustained Virological Suppression on HAART
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
587
0 countries
N/A
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is non-inferior to continuing triple-therapy, in terms of the proportion of patients who maintain all the drug treatment options that were available to them at baseline after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 27, 2010
Actual (reported)October 29, 2010
Actual (reported)November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Loss of future drug options
The first occurrence of intermediate to high level resistance to any one or more of the standard antiretroviral drugs (limited to licensed drugs in contemporary use) to which the patient's virus was considered to be sensitive at trial entry (i.e. excluding drug resistance that was known to be present on previous resistance testing).
Up to 5 years
Death from any cause
Up to 5 years
Serious AIDS-defining illness
Up to 5 years
Ritonavir-boosted protease inhibitor
Standard-of-care triple-therapy regimen
Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor
Winston A, Arenas-Pinto A, Stohr W, Fisher M, Orkin CM, Aderogba K, De Burgh-Thomas A, O'Farrell N, Lacey CJ, Leen C, Dunn D, Paton NI; PIVOT Trial Team. Neurocognitive function in HIV infected patients on antiretroviral therapy. PLoS One. 2013 Apr 30;8(4):e61949. doi: 10.1371/journal.pone.0061949. Print 2013.
Nick Paton, MD
Medical Research Council
587 participants (actual enrollment reported by the registry).
First Submitted
October 27, 2010
First Posted
October 29, 2010
Study Start
November 2008
Date type not reportedThis date has not been verified as actual or estimated.
DART II - A Phase IV Study of 3 Antiretroviral Medicines in Combination, in HIV Patients Who Have Not Been Previously Treated With Antiretroviral Therapy
Serious non-AIDS defining illness
Up to 5 years
Adverse events
Up to 5 years
Confirmed Virological rebound
Up to 5 years
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 10, 2012
Record last verified: 2010-10
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Source: ClinicalTrials.gov.
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